Evaluation of the Safety of Relaxin in Preeclampsia

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

ClinicalTrials.gov Identifier:

NCT00333307

First Posted: June 5, 2006

Last Update Posted: March 16, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by:

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

Further study details as provided by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies:

Primary Outcome Measures:

maternal adverse experiences

fetal adverse experiences

neonatal adverse experiences

Secondary Outcome Measures:

preeclampsia assessments

vital signs

physical examinations

clinical laboratory assessments

Estimated Enrollment:

18

Study Start Date:

October 2006

Detailed Description:

The effects of relaxin may be beneficial in the treatment of women with preeclampsia. This study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women with severe preeclampsia.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 40 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosis of preeclampsia

Hospital admission for expectant management

Exclusion Criteria:

Eclampsia or history of seizures

Vaginal bleeding

Multifetal gestation

Requirement for immediate delivery

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333307

Locations

United States, Kentucky

Central Baptist Hospital

Lexington, Kentucky, United States, 40503

United States, Ohio

University of Cincinnati

Cincinnati, Ohio, United States, 45267

Sponsors and Collaborators

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

Investigators

Study Director:

Sam Teichman, MD

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies